Efficacy of Ethyl Chloride Topical Anesthesia Application on the Pain Perception During Intra-oral Injections in Children in Comparison to Benzocaine Gel.

Anesthesia, Local Clinical Trial

Official title:

Efficacy of Ethyl Chloride Topical Anesthesia Application on the Pain Perception During Intra-oral Injections in Children in Comparison to Benzocaine Gel- a Single-blinded Randomized Controlled Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06011005
• Other study ID #: MBRU IRB-2022-174
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: August 2023
• Source: Mohammed Bin Rashid University of Medicine and Health Sciences
• Contact: Nagah Abdelrahman
• Phone: 971551225599
• Email: Nagah.abdelrahman[@]residents.mbru.ac.ae
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this single-blinded randomized controlled trial is to compare pain perception during buccal infiltration using indirect EC spray and topical anesthesia and BC 20% topical gel, among seven to 10-year-old school children who attended Pediatric Dentistry Department at Dubai Dental Hospital (DDH), Mohammed Bin Rashid University (MBRU) in Dubai, the United Arab Emirates (UAE).

The main question[s] it aims to answer are:

• How effective is the indirect application of EC topical spray anesthesia on pain perception during intraoral buccal injection in children in comparsion to BC 20%?

Researchers will compare efficacy of 20% Benzocaine (BC) gel and indirect application of Ethyl Chloride (EC) spray to see if reducing pain perception during local anesthesia infiltration.

Description:

Pre-local analgesia topical Benzocaine gel or Ethyl Chloride technique will be selected randomly and applied per the protocol. A single calibrated operator (A.A) using randomly selected sealed envelopes that have been previously divided equally according to sample size arms. The selected envelope is then opened by the operator, who applies either the EC or BC topical anesthesia technique based on the chosen envelop. Followed by maxillary local analgesia buccal infiltration for a single tooth by a calibrated operator (A.A). The child is then observed and assessed by the blinded primary investigator (N.A) (to the topical anesthesia technique) for pain perception during local anesthesia infiltration based on the Sound, Eye, Motor index used in this study. The child is then asked to rate the Visual Analog Scale and Facial Pain Scale. Heart rate of the patient will be recorded as per below protocol.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: December 31, 2023
• Est. primary completion date: October 24, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 10 Years

Eligibility

Inclusion Criteria:

• Healthy children (ASA I) aged between 7 - 10 years old.

• Needing any maxillary buccal infiltration (anterior, middle, posterior)

• Had no prior history of local anesthesia.

• Frankl behavior III or IV

• Not taking any painkillers, or other drugs that would influence with their pain perception.

Exclusion Criteria:

• History of a medically compromised condition and intellectual disability. § Any allergy to local anesthesia.

• Active pathology at the site of injection.

• Prior history of intra-oral injection.

• Frankl behavior I or II.

• Children/parents not willing to participate in the study. § Needle phobia.

• Patients require treatment under conscious sedation.

Related Conditions & MeSH terms

• Anesthesia, Local
• Dental Caries
• Dental Caries in Children
• Injection Site Discomfort

Intervention

Other:
• Ethyl Chloride spray (group A)
Cold test spray
• Benzocaine gel 20% (group B)
Topical analgesia

Locations

Country	Name	City	State
United Arab Emirates	Mohammed Bin Rashid University Of Medicine and Health Sciences	Multiple Locations

Sponsors (1)

Lead Sponsor	Collaborator
Mohammed Bin Rashid University of Medicine and Health Sciences

Country where clinical trial is conducted

United Arab Emirates, 

References & Publications (20)

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* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate	Each participant's heart rate will be recorded immediately before and after the injection using an FDA-approved pulse oximeter.	5-10 minutes
Secondary	Sound, Eye, Motor (SEM) Index	During the insertion of the needle, the operator will evaluate the patient's behavior for pain perception using sound, eye, motor (SEM) scale and visual analog scale (VAS).	5-10 minutes
Secondary	Visual Analog Scale (VAS)	The VAS scale is a 100-mm long horizontal line labeled "no pain: at one end and "worst pain possible" at the other. After each procedure (EC or BC), the participants are asked to evaluate the degree of pain (primary outcome) they experienced using the Facial Pain Scale below.	5-10 minutes
Secondary	Face Pain Scale	These faces show how much something can hurt. This face (point to leftmost face] shows no pain. The faces show more and more pain [point to each from left to the right] up to this one [point to rightmost face] - it shows very much pain. Point to the face that shows how much the child is hurt. Score the chosen face 0, 2, 4, 6, 8, or 10, counting left to right, so ''0' = 'no pain' and ''10' = 'very much pain. Do not use words like "happy' and ''sad'. This scale is intended to measure how children feel inside, not how their face looks. Brief word instructions: Point to each face using the words to describe the pain intensity. Ask the children to choose a face that best describes their pain and record the appropriate number.	5-10 minutes